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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Motordrive Unit (MD5)
BOSTON SCIENTIFIC CORPORATION
H749I50330
In Commercial Distribution

  • 08714729229513 ()


  • Cardiovascular ultrasound imaging system
Disposable Pullback Sled for Motordrive
BOSTON SCIENTIFIC CORPORATION
H749A70200
In Commercial Distribution

  • 08714729228684 ()


  • Cardiovascular ultrasound imaging system
Holter Analysis Enhanced Plus
Northeast Monitoring, Inc.
Enhanced Plus
In Commercial Distribution

  • M581NEMK1620 ()
NEMK162

  • Cardiac arrhythmia monitoring system
Holter Analysis Software Enhanced
Northeast Monitoring, Inc.
Enhanced
In Commercial Distribution

  • M581NEMK1610 ()
NEMK161

  • Cardiac arrhythmia monitoring system
Holter Analysis Software Basic
Northeast Monitoring, Inc.
Basic
In Commercial Distribution

  • M581NEMK1600 ()
NEMK160

  • Cardiac arrhythmia monitoring system
Installed Basic System
BOSTON SCIENTIFIC CORPORATION
H749ILAB240INS0
In Commercial Distribution

  • 08714729765127 ()


  • Cardiovascular ultrasound imaging system
Cart System
BOSTON SCIENTIFIC CORPORATION
H749ILAB100CART0
In Commercial Distribution

  • 08714729761235 ()


  • Cardiovascular ultrasound imaging system
Installed Basic System
BOSTON SCIENTIFIC CORPORATION
H749ILAB100INS0
In Commercial Distribution

  • 08714729119593 ()


  • Cardiovascular ultrasound imaging system
Mapping System
BOSTON SCIENTIFIC CORPORATION
M004RBINSTALL2ENR0
In Commercial Distribution

  • 08714729994077 ()


  • Cardiac mapping system
No Description
BOSTON SCIENTIFIC CORPORATION
H7495554280
In Commercial Distribution

  • 08714729986089 ()
H7495554280

  • Cardiovascular ultrasound imaging system
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